Effects of Disease Management on Development of End Stage Renal Disease in Type 2 Diabetic Patients With Nephropathy

August 21, 2015 updated by: Juliana Chan, Chinese University of Hong Kong

A Multicentre, Randomised Study to Examine the Effects of Disease Management on Development of End Stage Renal Disease in Type 2 Diabetic Patients With Nephropathy

Disease management using a multidisciplinary team to achieve and maintain optimal metabolic and cardiovascular risk factors control in Type 2 diabetic patients with nephropathy reduces the incidence of end stage renal disease (ESRD) and improves clinical outcomes compared to usual clinic-based care

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetic patients consume over 10% of health care costs in most developed countries. Over 80% of these resources are used to treat diabetic complications and late stage diseases. Over 30% of patients admitted to the medical wards in Hong Kong's public hospitals have diabetes, mainly due to cardiovascular and renal complications. Diabetes is now the leading cause of end stage renal disease (ESRD), accounting for 30-50% of patients on renal replacement therapy (RRT). In Hong Kong, the number of patients receiving RRT have increased by 50% in the last 5 years but the number of patients with ESRD due to diabetes have doubled. Between 10% and 15% of patients attending medical clinics in local public hospitals either receive insulin or anti-diabetic drugs. In both community and hospital settings, between 30% and 50% of diabetic patients have albuminuria, which is by far the most powerful predictor for early mortality, cardiovascular morbidity and renal disease. Local published data show that 3-10% of diabetic patients died or developed clinical endpoints yearly.

There are now overwhelming evidence supporting the beneficial effects of optimal control of cardiovascular risk factors on clinical outcomes in diabetic patients. However, there are few studies to examine the most effective way to translate these scientific evidence collected in closely monitored clinical trial situations into daily clinical practice. Results from this multi-centre, randomized study will provide important information to health care policy makers regarding the cost effectiveness of disease management using a multidisciplinary team to deliver a structured care model in light of the growing diabetes epidemic and the constraints of finite resources and the need for equity.

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Type 2 diabetic patients with ages between 35 and 75 years (inclusive) and defined according to the 1998 WHO criteria and no history of unprovoked ketosis and not requiring continuous insulin treatment within 1 year of diagnosis
  2. Plasma creatinine 150-350 mmol/l (inclusive) who had no microscopic haematuria and no ultrasonographic evidence of obstructive uropathy which is amenable to surgical intervention

Exclusion Criteria:

  1. patients with malignancy or other life-threatening diseases
  2. ultrasonographic evidence of obstructive uropathy which is amenable to surgical intervention
  3. non-diabetes related renal disease such as glomerulonephritis proven on renal biopsy reversible kidney disease, to be ruled out by ultrasonographic examination
  4. patients with clinically unstable psychiatric illnesses
  5. Patients who have 2 consecutive values of plasma creatinine concentration which differ by more than 20% within 3 months prior to recruitment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death and/or ESRD defined as need for dialysis or plasma creatinine 500mmol/l
Time Frame: May 2003 - Dec 2007
May 2003 - Dec 2007

Secondary Outcome Measures

Outcome Measure
Time Frame
Composite cardiovascular endpoints (acute myocardial infarction, revascularisation procedures, heart failure or unstable angina or arrhythmia requiring hospital admissions, lower extremity amputation)
Time Frame: May 2003 - Dec 2007
May 2003 - Dec 2007
Number of hospital admissions, total number of days of hospital stay and attendance at the Accident and Emergency Department
Time Frame: May 2003 - Dec 2007
May 2003 - Dec 2007

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Juliana CN Chan, MB ChB, MD, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, The Prince of Wales Hospital, Shatin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

March 30, 2006

First Submitted That Met QC Criteria

March 30, 2006

First Posted (Estimate)

March 31, 2006

Study Record Updates

Last Update Posted (Estimate)

August 24, 2015

Last Update Submitted That Met QC Criteria

August 21, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2004.226-T
  • HCPF No. 121012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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